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Nembutal [Pentobarbital] Injection and Seconal [Secobarbital] Capsules

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Nembutal [Pentobarbital] Injection and Seconal [Secobarbital] Capsules Pharmacy Benefit Coverage Criteria Effective Date .......................................... 12/1/2020 Next Review Date… ................................... 12/1/2021 Coverage Policy Number ................................ P0095 Nembutal [pentobarbital] injection and Seconal [secobarbital] capsules Table of Contents Related Coverage Resources Overview .............................................................. 1 Coverage Policy ................................................... 1 FDA Summary ..................................................... 1 General Background ............................................ 2 References .......................................................... 2 INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. Overview This policy addresses the usage of (Nembutal [pentobarbital] injection and Seconal [secobarbital] capsules) in an outpatient setting. The policy does not address potential use for individuals in an in-patient or hospitalized setting. Coverage Policy The use of Nembutal [pentobarbital] injection and Seconal [secobarbital] capsules in an outpatient setting for any use is considered not medically necessary. Note: Nembutal [pentobarbital] injection and Seconal [secobarbital] are FDA approved for the short-term management of insomnia or as pre-anesthesia; however, current clinical practice guidelines do not support these uses. FDA Summary Nembutal (pentobarbital) injection1 is FDA approved for the following indications: Page 1 of 3 Pharmacy Benefit Clinical Criteria: P0095 • Anesthesia, adjunct • Insomnia, short-term treatment • Sedation • Seizure, in emergency control of certain acute convulsive episodes Seconal (secobarbital) capsules2 are FDA approved for the following indications: • Anesthesia, adjunct • Insomnia, short-term treatment Nembutal (pentobarbital) is available as a 50 mg/mL injectable solution in 20 mL and 50 mL vials. Seconal (secobarbital) is available as 100 mg capsules. General Background Guidelines American Academy of Sleep Medicine (AASM) clinical practice guidelines state that although included as an FDA-approved use in the manufacturer's prescribing information for the short-term treatment of insomnia, the use of barbiturates, such as pentobarbital and secobarbital, is no longer recommended for the treatment of insomnia. The guidelines provide a weak recommendation to use doxepin, eszopiclone, ramelteon, suvorexant, temazepam, triazolam, zaleplon or zolpidem for the treatment for sleep maintenance insomnia, versus no treatment, in adults.3 Potentially inappropriate medication use is a concern for all patients. The Centers for Medicare & Medicaid Services (CMS) now consider potentially inappropriate medication use to be an integral part of policy and practice in order to decrease the use of these drugs and improve clinical outcomes in elderly patients. One of the most frequently cited consensus criteria documents published on the inappropriate use of medications in the elderly is the Beers Criteria or Beers List.4 The Beers list was developed by a United States expert panel using a comprehensive, systematic review and grading of the evidence on drug-related problems and adverse drug events in older adults. The updated (2012) Beers List details 53 medications or classes of medications and divides them into three categories: 1) Potentially inappropriate medications that should generally be avoided in older adults because they are either ineffective or they pose unnecessary high risk where an alternative drug or non-drug therapy is appropriate, 2) Potentially inappropriate medications that should be avoided in older adults with certain diseases that the Beers List drug(s) can exacerbate and, 3) Potentially inappropriate medications that should be used with caution in older adults. One of the medication classes detailed in the Beers List is the barbiturates. The Beers List includes the following barbiturates: amobarbital, butabarbital, butalbital, pentobarbital, phenobarbital, and secobarbital with a recommendation to avoid due to the high rate of physical dependence, tolerance to sleep benefits, and risk of overdose at low dosages. The Beers List notes that all of these drugs with the exception of phenobarbital and butalbital (as part of combination products used for the treatment tension headaches and mild pain) are infrequently used medications.4 The National Committee for Quality Assurance details the Healthcare Effectiveness Data and Information Set (HEDIS) tool measures which are used by health care plans to measure performance in important aspects of care and services.5 One of the HEDIS measures is a modified version of the Beers List Criteria, and is called Use of High-Risk Medications (HRM) in the Elderly.6 The Beers List described above was recently updated (2012) and as of the time this policy was written there were no known updates to the HEDIS HRM in the Elderly List. References 1. Nembutal (pentobarbital) [prescribing information]. Lake Forest, IL: Akorn Inc; February 2020. Page 2 of 3 Pharmacy Benefit Clinical Criteria: P0095 2. Seconal (secobarbital) [prescribing information]. Northbrook, IL: Marathon Pharmaceuticals, LLC. August 2013. 3. Sateia MJ, Buysse DJ, Krystal AD, Neubauer DN, Heald JL. Clinical practice guideline for the pharmacologic treatment of chronic insomnia in adults: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2017;13(2):307-349 4. The American Geriatrics Society 2012 Beers Criteria Update Expert Panel. American Geriatrics Society Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. J Am Geriatr Soc. 2012 Feb 29. Doi: 10.1111/j.1532-5415.2012.03923.x. [Epub ahead of print]. Accessed April 7, 2013. Available at: http://www.americangeriatrics.org/files/documents/beers/2012BeersCriteria_JAGS.pdf 5. National Committee for Quality Assurance. The State of Health Care Quality 2011. Continuous Improvement and the Expansion of Quality Measure. Accessed April 7, 2013. Available at: http://www.ncqa.org/Portals/0/State%20of%20Health%20Care/2010/SOHC%202010%20-%20Full2.pdf 6. National Committee for Quality Assurance. Use of high-risk medications in the elderly. Accessed March 14, 2012. Available at: http://www.ncqa.org/Portals/0/Newsroom/SOHC/Drugs_Avoided_Elderly.pdf. “Cigna Companies” refers to operating subsidiaries of Cigna Corporation. All products and services are provided exclusively by or through such operating subsidiaries, including Cigna Health and Life Insurance Company, Connecticut General Life Insurance Company, Cigna Behavioral Health, Inc., Cigna Health Management, Inc., QualCare, Inc., and HMO or service company subsidiaries of Cigna Health Corporation. The Cigna name, logo, and other Cigna marks are owned by Cigna Intellectual Property, Inc. © 2020 Cigna. Page 3 of 3 Pharmacy Benefit Clinical Criteria: P0095 .
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